A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

InSightec

Status: Enrolling

Conditions: Tremor Associated With Tremor Dominant Parkinson's Disease

Treatments: Device: Unilateral thalamotomy

Study type: Observational

Funder types: Industry

Identifiers

NCT04991831

PD012

Details and patient eligibility

About

The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.

Full description

This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treatment of medication refractory Tremor Dominant Parkinson's Disease (TDPD). Subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available Exablate Neuro for the treatment of Essential tremor and TDPD.

The following assessments will be collected at Baseline,1, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years:

• Adverse Events (AEs) (does not apply to Baseline Visit)
• Medication usage
• Clinical Rating Scale for Tremor (CRST) ON medication
• Unified Parkinson's Disease Rating Scale Part III ON medication
• EQ-5D-5L
• WPAI-GH

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women, age 30 years and older
2. Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
3. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
4. Subject has signed and received a copy of the approved informed consent form

Exclusion criteria

Subject does not agree to participate or is unlikely to participate for the entirety of the study.

Trial design

50 participants in 1 patient group

Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease

Description:

This is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol.

Treatment:

Device: Unilateral thalamotomy